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Validation of Sterilization Processes and USP/AAMI Microbiology, Cleanroom Practices, Aseptics, etc.
Expert has years of experience in validating EO sterilization systems per ISO 11135, Gamma sterilization systems per ISO 11137, and Steam sterilization systems per ISO 11134/17665. This would also include troubleshooting and cycle development issues. He has worked with large…
Electronic and Mechanical Design of Consumer and Healthcare Products for Asian Manufacture
Expert has a biomedical engineering degree from MIT (option of electrical engineering). He was instrumental in the development of an acoustic-based diagnostic instrument for the detection of otitis media (fluid in the ear due to ear infection). The product was…
Safety Management in Industry and Construction
At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma…
Microbiology, Biotechnology, Cleanroom Microbiology, Sterilization, etc.
As a consultant, Expert has used his broad-based scientific background to work with a variety of clients. These clients have required expertise in such widely divergent subjects as the production of cellulosic ethanol (requiring a knowledge of basic thermodynamics, enzyme…
Microcontroller-based Product Design
Most of the projects expert has been involved with have been real-time dependent. He has designed high-speed bit-slice-based data acquisition units for military aircraft radar, high-speed machinery controls, home automation, cordless telephones, fitness equipment, arcade games, and other consumer products.…
Sterilization, Sterilizers
STERILIZATION; STERILIZER; AUTOCLAVE. Expert has over twenty years of experience in the design, production, and marketing of steam and gas sterilization equipment. His experience has covered small table top sterilizers through large bulk processing units. He has been responsible for…
Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology
Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…